MAUDE Adverse Event Report: BATTLE CREEK EQUIPMENT THERMOPHORE; THEMOPHORE

Model Number 055

Device Problems Thermal Decomposition of Device (1071); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Customer stated "there was a hot spot and a burn mark".Product was returned.Customer did not claim injury.The investigation found no evidence of burn marks and observed that the user laying on/ folding the pad while in use.It was determined that this misuse caused the formation of the hot spots.Ifu states, "do not sit on, lie on, or crush pad.Avoid sharp folds".

• Brand Name: THERMOPHORE
• Type of Device: THEMOPHORE
• Manufacturer (Section D): BATTLE CREEK EQUIPMENT; 702 s reed rd; fremont IN 46737
• Manufacturer Contact: michael green
• MDR Report Key: 9430164
• MDR Text Key: 176113013
• Report Number: 1832415-2019-10890
• Device Sequence Number: 1
• Product Code: IRT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 055
• Device Lot Number: 00553514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1